Determination of purity of a new anti-fatty liver drug IMH by differential scanning calorimetry method and uncertainty evaluation
10.16438/j.0513-4870.2022-1373
- VernacularTitle:抗脂肪肝新药IMH的差示扫描量热法纯度定值研究及不确定度评估
- Author:
Hui-hui SHAO
;
Kang-fan LEI
;
Tong QIN
;
Wen-xuan ZHANG
;
Song WU
;
Qing-yun YANG
- Publication Type:Research Article
- Keywords:
anti fatty liver drug;
ifferential scanning calorimetry;
purity determination;
uncertainty;
quality control
- From:
Acta Pharmaceutica Sinica
2023;58(3):767-772
- CountryChina
- Language:Chinese
-
Abstract:
The purity of 4,4′-dimethoxy-5,6,5′,6′-bis (methylenedioxy)-2′-morpholine methylenebiphenyl-2-methyl formate methanesulfonate (IMH), a new drug for fatty liver treatment, was determined through differential scanning calorimetry (DSC). Analysis of two-factor non repeatability method was performed in the investigation the effects of two factors (heating rate and sample weight) on purity determination. The DSC experimental parameters were optimized as follows: heating rate was 10 ℃·min-1, temperature range was 150-300 ℃, sample weight was 2.0-4.1 mg, and N2 flow rate was 80 mL·min-1. The linear correlation coefficient (r) of this DSC method was 0.999 8. The RSD value (n = 6) of precision was 0.03%. The standard value and uncertainty of the purity results of the multiple batches of IMH drugs were (99.74 ± 0.29)%, (99.91 ± 0.28)%, (99.90 ± 0.28)%, and (99.81 ± 0.28)% with inclusion factor (K) of 2 and confidence probability (P) of 0.95. The results were basically consistent with the results of the mass balance method. The DSC mehod is a simple, rapid and accurate method, and provides a new reference method for determining the purity of IMH drugs, improves the accuracy and reliability of purity determination.
